Condition

Intervention

The ACTION study is a cluster randomised control trial in which potential participants are randomised in groups (i.e. the group is randomised not the individual). In this case, the hospitals taking part in the study are treated as the cluster of patients and randomised as a unit.Pairs of comparable hospitals have been randomised at the start of the study to provide either advance care planning (in the intervention hospitals) or 'standard care' ( in the control hospitals). In this study, only the intervention hospitals will be exposed to the 'Respecting Choices Program' but it is acknowledged that other advance care planning activities may take place in the control hospitals as part of 'standard care'. The 'Respecting Choices Program' is a formalised model of advance care planning developed and currently being used in the United States and Australia. In this programme, a trained 'Respecting Choices Facilitator' invites patients to reflect on their personal goals, values and beliefs, to discuss and document their choices regarding their future treatment and care and to nominate someone who they may wish to be consulted about their treatment or care if they are not able to make decisions for themselves. After consenting to take part in the study, participants in the intervention hospitals are invited to take part in two advance care planning interviews with a trained 'Respecting Choices' facilitator in a location convenient to the patient. Patients will continue to be under the care of their health care team while on the study and after their involvement in the study has ended.

Intervention type

Other

Phase

Phase III

Drug names

Primary outcome measure

Quality of life and symptoms; Timepoint(s): Baseline, 10-12 and 18-20 weeks (both control and intervention group)

Overall trial start date

01/11/2014

Overall trial end date

30/11/2018

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Adult patients with advanced stages of lung or colorectal cancer. Patients need to have an estimated life expectancy of at least three months. The patients will be under the care of the oncologist at the participating hospitals.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 1360; UK Sample Size: 272

Participant exclusion criteria

1. Age less than 18 years2. Unable to provide consent3. Unable to complete questionnaire in country's language4. Less than 3 months anticipated life expectancy5. Taking part in a research study that is evaluating palliative care services or communication strategies

Intention to publish date

Participant level data

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

20/12/2017: The following changes were made:
1. The overall trial end date was updated from 31/12/2016 to 30/11/2018.
2. The recruitment end date was updated from 31/12/2016 to 01/06/2018.
3. Publication plan, patient level data and two trial participating centres were added.
4. Dr Nancy Preston replaced Miss Lesley Dunleavy as the study contact.
12/04/2016: Publication reference added.
On 17/11/2014 the Netherlands, Italy, Belgium, Denmark and Slovenia were added to the countries of recruitment.